EUCTR2011-005868-25-Outside-EU/EEA进行中（未招募）不适用
A randomised, open-label study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2-3-4 or 3-4-5 months of age in healthy infants in China. - DTPA-IPV (INFANRIX-IPV)-056
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 985
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- •Born after a gestation period of 36 to 42 weeks, inclusive.
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 985
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Child in care.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period with the exception of hepatitis B vaccine.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or serious chronic illness.
- •The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature > 37.00°C or other moderate to severe illness within 24 hours of study vaccine administration.
研究者
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